The US Food and Drug Administration (FDA) has accepted Alkermes’ resubmission of the New Drug Application for ALKS 3831, a combination of olanzapine and samidorphan, the company announced.
The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of June 1, 2021, to the application, according to a statement from Alkermes.
ALKS 3831 is proposed for the treatment of adults with schizophrenia and for the treatment of adults with bipolar I disorder. It is a novel, once-daily, oral atypical antipsychotic that combines samidorphan, a new molecular entity, with olanzapine in a bilayer tablet.
In October, two FDA advisory committees voted in favor of the drug, with a majority agreeing that samidorphan meaningfully mitigates weight gain associated with olanzapine and that its safety profile has been adequately characterized, according to Alkermes.
In November, the FDA issued a Complete Response Letter (CRL) stating conditions related to the tablet coating process at one of Alkermes’ facilities were required to be resolved before the drug could be approved. The letter did not raise any concerns about clinical data and no new clinical trials are required.